[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100477993":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":32,"centralContacts":33,"locations":32,"responsibleParty":38,"collaborators":32,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":32,"eligibilityCriteria":46,"healthyVolunteers":42,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":32,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":65,"whyStopped":32,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":32},{"fullName":5,"class":6},"Kira Pharmacenticals (US), LLC.","INDUSTRY",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1: Dose Optimization Cohort 1, Dose 1","EXPERIMENTAL","Participants will be administered with KP104 as a weekly maintenance dose for 24 Weeks. After the last participant completes 6 weeks of treatment, all available data, including safety, PK, PD, and modeling results, will be reviewed by the Internal Data Review Committee (IDRC) to determine Dosing Regimen 2",[13],"Drug: KP104",{"label":15,"type":10,"description":16,"interventionNames":17},"Part 1: Dose Optimization Cohort 2, Dose 2","Participants will be administered with KP104 dose regimen 2 for 24 Weeks. After the last participant completes 6 weeks of treatment, all available data, including safety, PK, PD, and modeling results, will be reviewed by the IDRC to determine Dosing Regimen 3.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Part 1: Dose Optimization Cohort 3, Dose 3","Participants will be administered with KP104 dose regimen 3 for 24 Weeks. After the last participant completes 6 weeks of treatment, all available data, including safety, PK, PD, and modeling results, will be reviewed by IDRC to determine the Optimal biologic dose (OBD) for Part 2.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Part 2: OBD Cohort, Dose 4","Participants will be administered with KP104 OBD for 24 Weeks.",[13],[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","KP104","KP104 will be administered.",[9,15,19,23],null,[34],{"name":35,"role":36,"phone":32,"phoneExt":32,"email":37},"Study Director","CONTACT","privacy@kirapharma.com",{"type":39,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100477993","phase-2-study-to-evaluate-safety-tolerability-and-pharmacodynamics-of-kp104-in-participants-with-thrombotic-microangiopathy-secondary-to-systemic-lupus-erythematosus-100477993",false,"NCT05504187","Study to Evaluate Safety, Tolerability and Pharmacodynamics of KP104 in Participants With Thrombotic Microangiopathy Secondary to Systemic Lupus Erythematosus","An Open-label, Phase 2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of KP104 in Subjects With Thrombotic Microangiopathy Secondary to Systemic Lupus Erythematosus","Inclusion Criteria:\n\n* Meets criteria for SLE per the 2019 European League Against Rheumatism (EULAR)\u002FAmerican College of Rheumatology (ACR) criteria.\n* Decrease in platelet count to less than (\\\u003C)150,000\u002Fmicroliters (mcL).\n* Abnormal renal function.\n* Females of childbearing potential with negative pregnancy test and males must agree to practice effective contraception from Screening until 28 days after the End of study (EOS) visit.\n* Willing and able to provide informed consent.\n* Evidence of microangiopathic hemolytic anemia\n\nExclusion Criteria:\n\n* Diagnosis of other TMA syndromes.\n* A renal biopsy within 7 days of screening that shows exclusively chronic changes of TMA.\n* Positive Coombs test at the time of TMA diagnosis.\n* Active or unresolved Neisseria meningitidis infection at screening.\n\nOnly key inclusion and exclusion criteria have been included.","ALL","18 Years","65 Years",{"count":51,"type":52},24,"ESTIMATED","INTERVENTIONAL",[55],"PHASE2","This study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of KP104 in participants with systemic lupus erythematosus (SLE)-Thrombotic microangiopathy (TMA). The study consists of 2 parts: Part 1 (Dose Optimization) and Part 2 (Proof of Concept). All participants will receive KP104 in combination with standard of care (SOC) for SLE-TMA.",[58],"Systemic Lupus Erythematosus",[60,61,62,63,64],"Systemic lupus erythematosus","Thrombotic microangiopathy","Dose Selection","Proof of Concept","KP-104","NOT_YET_RECRUITING","2024-10-25",{"date":68,"type":69},"2024-10-28","ACTUAL",{"date":71,"type":52},"2025-03",{"date":73,"type":52},"2027-04",{"name":5,"class":6}]